Scientist 1, Global QC Raw Materials (Microbiology)

Position Overview

The Scientist 1, Global QC Raw Materials (Microbiology) liaises with various external collaborators, contract laboratory organizations, QC testing teams and QA groups to ensure training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with the pharmacopoeias and ICH guidelines. This role generates protocols and reports to support tech transfer activities and performs change control assessment activities for tech transfers to include, implementation of new raw materials, new test laboratories, specifications updates e.g. new methods and new vendors.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

Job Description

What You'll Do

 

• Supports RM tech transfer activities by implementing methods for Bioburden, Endotoxin and Identification of bacteria species either internally at FDB or at external CLO’s• Performs troubleshooting in close collaboration with FDB or external CLO’s to ensure suitable methods can be implemented• Authors protocols and reports for proving method suitability for internal FDB methods according to compendial requirements• Reviews and approves external protocols and reports for proving method suitability for CLO methods according to compendial requirements• Participates in internal and external investigations as SME to ensure compliance with FDB processes for deviations or out of specification’s (OOS) • Author strategy documents and updates relevant SOPs• Oversees compendial methods and scientific guidelines e.g. ICH, EMA, FDA etc• Performs other duties, as assigned

 

Minimum Requirements:

 

• Bachelor’s Master’s in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years’ experience OR• Master’s in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years’ experience OR• PhD with 1+ years of applicable industry experience• 4+ years of experience in a federally regulated GMP environment• Experience with method transfers• In-depth knowledge of Raw Material methodology as it pertains to cGMP

 

Preferred Requirements:

 

• In-depth knowledge of Raw Material methodology as it pertains to cGMP 

 

Physical and Work Environment Requirements:

 

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Will work in warm/cold environments (5 C)

Will work in small and/or enclosed spaces.

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requi